Last week, Jeremy Hunt, Chancellor of the Exchequer, published his Spring Budget for the UK. It identified life sciences and digital technologies as “high growth sectors,” which the UK Government wishes to prioritize. Among other things, the Budget outlined the Government’s plans to simplify medicines and technology approvals
Continue Reading UK MHRA to recognize foreign regulatory approvals for medicines and medical technologies and promote digital innovation
CJEU Provides Further Clarifications on Food for Special Medical Purposes
On 2 March 2023, the Court of Justice of the EU (“CJEU”) issued a preliminary ruling clarifying various aspects around the classification of products as foods for special medical purposes (“FSMPs”). The CJEU reinforced and supplemented its prior ruling in Case C-418/21 Orthomol (see our blog here for further details).
This case touches on a number of concepts in the FSMP definition. As a reminder, Article 2(2)(g) of Regulation (EU) 609/2013 (the “FSG Regulation”) defines an ‘FSMP’ as:
“food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone” (emphasis added).
In summary, the CJEU concluded:
- In determining the borderline between an FSMP and a medicine, all characteristics of the product need to be taken into account to determine whether it is intended to meet particular nutritional requirements or to prevent or cure human disease.
- The concept of ‘dietary management’ has to be understood to require a link between the disease and the nutritional requirements arising from it, the satisfaction of which is indispensable to the patient. The nutritional requirements do not necessarily have to be satisfied through digestion.
- The concept that the dietary management of the patient cannot be met through ‘modification of the normal diet alone’ means that meeting nutritional requirements through supplementing or changing the normal diet is impossible, dangerous or very difficult for the patient.
- The term ‘nutrient’ has to be interpreted in accordance with Regulation (EU) 1169/2011 on food information to consumers (the “FIC Regulation”).
- A product is ‘used under medical supervision’, “if the recommendation and subsequent assessment of a health professional are necessary in light of the dietary management needs arising from a particular disease, disorder or health condition and the effects of the product on the patient’s dietary management and on the patient” (paragraph 81).
- In determining the borderline between an FSMP and a food supplement, all characteristics of the product need to be taken into account to determine whether it is intended to meet the nutritional requirements of a patient that could not be achieved through regular diet or whether it is intended to supplement the normal diet.
Continue Reading CJEU Provides Further Clarifications on Food for Special Medical Purposes
German Government presents new law to incentivize paediatric medicines and antibiotics and to combat generics shortages
On 14 February 2023, the German Federal Ministry of Health (BMG) has presented the new draft “Act to Combat Supply Shortages of Off-Patent Medicines and to Improve the Supply of Paediatric Medicines” (Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetz or “ALBVVG”). Some commentators also refer to the new law
Continue Reading German Government presents new law to incentivize paediatric medicines and antibiotics and to combat generics shortagesEU Talking Life Sciences Audiocast: Episode 1 – Key Developments in the Pharma Sector: A Review of 2022 and Insights for 2023
Tune into the first episode of Covington’s Talking Life Sciences Audiocast, where Grant Castle, Peter Bogaert and Marie Doyle-Rossi discuss key developments and trends in the pharma sector. Our speakers review the major issues of 2022, including the Clinical Trials Regulation, the Health Technology Assessment Regulation, European Health
Continue Reading EU Talking Life Sciences Audiocast: Episode 1 – Key Developments in the Pharma Sector: A Review of 2022 and Insights for 2023Submit your views! Consultation on the New Global Biodiversity Fund Paid For by Life Sciences Companies that “Use Digital Sequence Information on Genetic Resources”
On 19 December 2022, the parties to the Convention on Biological Diversity (CBD) decided to create a new global mechanism requiring the private sector to pay into a new Global Biodiversity Trust Fund.
The new fund is expected to generate up to 15 billion USD per year, based on
Continue Reading Submit your views! Consultation on the New Global Biodiversity Fund Paid For by Life Sciences Companies that “Use Digital Sequence Information on Genetic Resources”
UK PMCPA Publishes First Ever Guidance to Pharmaceutical Companies about Social Media
On 26 January 2023, the UK’s Prescription Medicines Code of Practice Authority (“PMCPA”) published its “Social Media Guidance 2023” (the “Guidance”).
The Guidance is the first of its kind in the UK and is long-awaited.
The PMCPA is the self-regulatory body that administers and enforces the ABPI Code (the voluntary advertising code that many pharmaceutical companies adhere to in the UK). The ABPI Code sets out a number of overarching principles but does not address social media in detail. The PMCPA had some years ago published “digital guidelines” but these were archived for updating.
The first – and probably most important – thing to say about the Guidance is that it (finally) exists. Social media has become a major compliance headache for UK pharmaceutical companies. These days a significant number of PMCPA complaints, investigations and adjudications concern corporate or employee social media activity, particularly on LinkedIn. The absence of clear and codified guidance until now led to a lack of clarity. Key regulatory principles had evolved through a series of case rulings, which were often highly fact-dependent. While dissecting cases into the early hours may be interesting for us pharmaceutical advertising lawyers, compliance teams will likely appreciate having codified guidelines to refer to.
Secondly, the Guidance is likely to disappoint anyone hoping for seismic shifts in the PMCPA’s regulatory approach. Much of the Guidance aligns closely to rules and principles that had developed in the Authority’s case history. It also broadly aligns with EFPIA’s and IFPMA’s recently published “Guidelines Concerning the Use of Social Media and Digital Media Channels” (see our blog post).Continue Reading UK PMCPA Publishes First Ever Guidance to Pharmaceutical Companies about Social Media
CJEU Rules on the Advertising of “Unspecified Medicinal Products” in the EU
On 22 December 2022, the Court of Justice of the European Union (CJEU) — sitting in Grand Chamber — published its judgement in case C-530, Euroaptieka. The judgement adds further commentary to the meaning of “advertising medicinal products” in the EU and the competencies of EU Member States to restrict drug advertising activities. The judgement has particular implications for advertising “unspecified medicinal products”. No doubt, this judgement will be of interest to pharmaceutical companies and pharmacies looking at the communications activities they carry out in the EU and the risks entailed.Continue Reading CJEU Rules on the Advertising of “Unspecified Medicinal Products” in the EU
European Commission proposes significant changes to transition timelines of the Medical Device Regulation and IVD Regulation
Further to our discussion on the European Commission’s proposal to extend the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR), the Commission has adopted a formal proposal for a legislative amendment of the MDR and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and published a press release, Q&A and factsheet on the proposal. The proposal does not introduce any substantive changes to the broader MDR but focuses on amending the transitional provisions in the MDR.
The proposed changes to the MDR transition provisions aim to address concerns regarding Notified Body capacity and the significant number of medical devices yet to transition from the former Directives to the MDR. This situation is currently threatening the availability of such devices within the EU market.Continue Reading European Commission proposes significant changes to transition timelines of the Medical Device Regulation and IVD Regulation
Outcome from COP 15: a New Global Biodiversity Fund Paid For by Life Sciences Companies that “Use Digital Sequence Information on Genetic Resources”
A snapshot by yours truly while following the debate on synthetic biology. As you can see, business gets a seat in a place far, far away – in the back of the room.
After two weeks of intense negotiations in Montreal, on 19 December 2022, the Conference of the Parties (COP) to the Convention on Biological Diversity (CBD) adopted the new Global Biodiversity Framework. Covington partner Bart Van Vooren was on the ground as a business delegate to these talks.
Brief Summary
This blog explains one the most consequential outcomes for companies from COP15: the decision to set up a global mechanism requiring the private sector to pay into a new Global Biodiversity Trust Fund. The COP15 Decision was to decide to set up the mechanism immediately, and to tease out the details over the next two years. In short, the new fund is expected to generate up to 15 billion USD per year from companies that “use digital sequence information on genetic resources“. The revenue generated will then be disbursed in support of the four (4) Goals for 2050 and twenty-three (23) Targets for 2030 that together make up the Global Biodiversity Framework (GBF). This new mechanism will no doubt impact most life sciences companies, but the COP15 Press Release hinted at two sectors that are being singled out (my emphasis):
“Digital sequence information on genetic resources – a dominant topic at COP15 – has many commercial and non-commercial applications, including pharmaceutical product development, improved crop breeding, taxonomy, and the monitoring of invasive species.“
Reader beware, this blog is a long read. I will first provide some insight on the political narratives and financial expectations underpinning the new system, and then deep dive into the legal nitty-gritty and (un)knowns of the Decision on Digital Sequence Information (DSI) adopted by COP15.Continue Reading Outcome from COP 15: a New Global Biodiversity Fund Paid For by Life Sciences Companies that “Use Digital Sequence Information on Genetic Resources”
New Guidance on the Application of Article 97 of the MDR to Legacy Devices Certified under the MDD or AIMDD
It’s all happening in the device space. Further to the European Commission’s meeting we discussed last week on the proposed three-year extension to the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR), the EU Medical Device Coordination Group (MDCG) has now published guidance clarifying the use of the non-compliance procedure under Article 97 of the MDR.
Under Article 97, competent authorities can temporarily allow devices that do not comply with the MDR to continue to be placed on the market if they do not present an unacceptable risk to the health or safety of individuals or to public health.Continue Reading New Guidance on the Application of Article 97 of the MDR to Legacy Devices Certified under the MDD or AIMDD